SIST EN ISO 10993-10:2003
(Main)Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002)
Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002)
Migrated from Progress Sheet (TC Comment) (2000-07-10): Contact Mr Vyze ext 850 when processing this project through each stage
Biologische Beurteilung von Medizinprodukten - Teil 10: Prüfung auf Irritation und Allergien vom verzögerten Typ (ISO 10993-10:2002)
Dieser Teil der ISO 10993 beschreibt Verfahren für die Beurteilung von Medizinprodukten und ihren Bestandteilen hinsichtlich ihres Potentials, eine Irritation und eine Allergie vom verzögerten Typ hervorzurufen.
Dieser Teil der ISO 10993 enthält:
a) vor der Prüfung durchzuführende Überlegungen;
b) Einzelheiten zur Durchführung der Prüfungen und
c) Schlüsselfaktoren für die Interpretation der Ergebnisse.
Anlage A enthält Anweisungen für die spezielle Vorbereitung von Materialien im Zusammenhang mit den genannten Prüfungen.
Zusätzliche Prüfungen, die speziell für intrakutan und im Bereich der Augen, im Bereich der Mundhöhle, des Enddarms, des Penis oder der Vagina anzuwendende Produkte erforderlich sind, gibt der Anhang B.
Evaluation biologique des dispositifs médicaux - Partie 10: Essais d'irritation et d'hypersensibilité retardée (ISO 10993-10:2002)
Biološko ovrednotenje medicinskih pripomočkov - 10. del: Preskusi draženja in zakasnjene preobčutljivosti (ISO 10993-10:2002)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-marec-2003
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SIST EN ISO 10993-10:2000
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Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type
hypersensitivity (ISO 10993-10:2002)
Biologische Beurteilung von Medizinprodukten - Teil 10: Prüfung auf Irritation und
Allergien vom verzögerten Typ (ISO 10993-10:2002)
Evaluation biologique des dispositifs médicaux - Partie 10: Essais d'irritation et
d'hypersensibilité retardée (ISO 10993-10:2002)
Ta slovenski standard je istoveten z: EN ISO 10993-10:2002
ICS:
11.100.20 %LRORãNRRYUHGQRWHQMH Biological evaluation of
PHGLFLQVNLKSULSRPRþNRY medical devices
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 10993-10
NORME EUROPÉENNE
EUROPÄISCHE NORM
September 2002
ICS 11.100 Supersedes EN ISO 10993-10:1995
English version
Biological evaluation of medical devices - Part 10: Tests for
irritation and delayed-type hypersensitivity (ISO 10993-10:2002)
Evaluation biologique des dispositifs médicaux - Partie 10: Biologische Beurteilung von Medizinprodukten - Teil 10:
Essais d'irritation et d'hypersensibilité retardée (ISO 10993- Prüfung auf Irritation und Allergien vom verzögerten Typ
10:2002) (ISO 10993-10:2002)
This European Standard was approved by CEN on 5 August 2002.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2002 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10993-10:2002 E
worldwide for CEN national Members.
CORRECTED 2002-11-27
Foreword
This document (EN ISO 10993-10:2002) has been prepared by Technical Committee ISO/TC
194 "Biological evaluation of medical devices" in collaboration with Technical Committee
CEN/TC 206 "Biocompatibility of medical and dental materials and devices", the secretariat of
which is held by NEN.
This document supersedes EN ISO 10993-10:1995.
This European Standard shall be given the status of a national standard, either by publication of
an identical text or by endorsement, at the latest by March 2003, and conflicting national
standards shall be withdrawn at the latest by March 2003.
This document has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association, and supports essential requirements of EU
Directive(s).
For relationship with EU Directive(s), see informative Annex ZB, which is an integral part of this
document.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium, Czech
Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg,
Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 10993-10:2002 has been approved by CEN as EN ISO 10993-10:2002 without
any modifications.
NOTE Normative references to International Standards are listed in Annex ZA (normative).
Annex ZA
(normative)
Normative references to international publications
with their relevant European publications
This European Standard incorporates by dated or undated reference, provisions from other
publications. These normative references are cited at the appropriate places in the text and the
publications are listed hereafter. For dated references, subsequent amendments to or revisions of
any of these publications apply to this European Standard only when incorporated in it by
amendment or revision. For undated references the latest edition of the publication referred to
applies (including amendments).
NOTE Where an International Publication has been modified by common modifications, indicated by (mod.),
the relevant EN/HD applies.
Publication Year Title EN/HD Year
ISO 10993-1 1997 Biological evaluation of medical devices - EN ISO 10993-1 1997
Part 1: Evaluation and testing
ISO 10993-2 1992 Biological evaluation of medical devices - EN ISO 10993-2 1998
Part 2: Animal welfare requirements
ISO 10993-9 1999 Biological evaluation of medical devices - EN ISO 10993-9 1999
Part 9: Framework for identification and
quantification of potential degradation
products
ISO 10993-12 1996 Biological evaluation of medical devices - EN ISO 10993-12 1996
Part 12: Sample preparation and reference
materials
ISO 10993-13 1998 Biological evaluation of medical devices - EN ISO 10993-13 1998
Part 13: Identification and quantification of
degradation products from polymeric
medical devices
ISO 10993-14 2001 Biological evaluation of medical devices - EN ISO 10993-14 2001
Part 14: Identification and quantification of
degradation products from ceramics
ISO 10993-15 2000 Biological evaluation of medical devices - EN ISO 10993-15 2000
Part 15: Identification and quantification of
degradation products from metals and
alloys
Annex ZB
(informative)
Clauses of this European Standard addressing essential requirements or
other provisions of EU Directives
This European Standard has been prepared under a mandate given to CEN by the European
Commission and the European Free Trade Association and supports essential requirements of
EU Directive 93/42/EEC.
WARNING Other requirements and other EU Directives may be applicable to the product(s)
falling within the scope of this standard.
The following clauses of this standard are likely to support requirements of Directive 93/42/EEC.
Compliance with these clauses of this standard provides one means of conforming with the
specific essential requirements of the Directive concerned and associated EFTA regulations.
Table ZB.1— Correspondence between this European Standard and EU Directive 93/42/EEC
Clause/subclause of this Corresponding Essential Comments
European Standard Requirement of Directive
93/42/EEC
6 7.1 of Annex I
B.2 7.1 of Annex I
B.3
B.4
B.5 7.2 of Annex I
B.6
B.7
INTERNATIONAL ISO
STANDARD 10993-10
Second edition
2002-09-01
Biological evaluation of medical devices —
Part 10:
Tests for irritation and delayed-type
hypersensitivity
Évaluation biologique des dispositifs médicaux —
Partie 10: Essais d'irritation et d'hypersensibilité retardée
Reference number
ISO 10993-10:2002(E)
©
ISO 2002
ISO 10993-10:2002(E)
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ISO 10993-10:2002(E)
Contents Page
Foreword . iv
Introduction. vi
1 Scope. 1
2 Normative references. 1
3 Terms and definitions. 2
4 General principles — Step-wise approach . 3
5 Pretest considerations. 4
5.1 General . 4
5.2 Types of material. 4
5.3 Information on chemical composition . 4
5.4 Material characterization . 5
6 Irritation tests . 5
6.1 In vitro irritation tests . 5
6.2 Factors to be considered in design and selection of in vivo tests . 5
6.3 Animal skin irritation test . 6
6.4 Human skin irritation test. 10
7 Delayed hypersensitivity tests. 14
7.1 Choice of test. 14
7.2 Choice of test sample concentrations . 14
7.3 Other important factors affecting the outcome of the test . 14
7.4 Maximization test for delayed hypersensitivity . 15
7.5 Closed-patch test for delayed hypersensitivity . 18
8 Key factors in interpretation of test results. 20
Annex A (normative) Preparation of materials for irritation/sensitization testing. 21
Annex B (informative) Additional irritation tests.23
Annex C (informative) Background information. 41
Bibliography. 45
ISO 10993-10:2002(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO
member bodies). The work of preparing International Standards is normally carried out through ISO technical
committees. Each member body interested in a subject for which a technical committee has been established has
the right to be represented on that committee. International organizations, governmental and non-governmental, in
liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical
Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3.
The main task of technical committees is to prepare International Standards. Draft International Standards adopted
by the technical committees are circulated to the member bodies for voting. Publication as an International
Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this part of ISO 10993 may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights.
...
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